Haemocompatibility and biological course of carbonaceous composites for cardiovascular devices.

ABSTRACT

A new class of carbonaceous composites has been developed for cardiovascular devices. The aim of the present study, performed in dogs, was to test the immediate blood compatibility of these materials when inserted within the vascular bed. Biocompatibility studies were performed on vascular cylinders (6 mm i.d.) and intra-atrial implants. The specimens were examined sequentially by SEM at 10, 20, 30, 180 s and 10 min after re-establishment of the blood flow. Patency of the vascular cylinders was tested during the second and third postoperative month by Doppler ultrasound investigations; specimens were examined by light and electron microscopy (scanning and transmission) at 15, 60 and 110 d following implantation. As early as 10 s after re-establishment of the blood flow platelet adhesion and a limited fibrin mesh with few erythrocytes developed on the material. Platelet aggregates were only observed on intravenous implants. Except in the case of the intravenous insert, no thrombosis developed at the contact of intra-arterial or intracardiac implants. After 15 d it was completely covered by a fibrocellular layer (3-5 cells thick) consisting of large myofibroblasts with microfilaments, newly synthesized collagen and elastin. Endothelial-like cells developed and were completed 2 mnth after implantation. However, deposits present inside and outside the fibrocytic cells of the newly developed tissue were observed corresponding to carbon peaks as indicated by wavelength dispersive X-ray microanalysis.